FDA Issues Final Guidance on Transitioning from COVID-19 EUAs
The FDA recently announced release of final transition guidance documents for medical diagnostic devices targeting COVID-19. The transition guidance documents are intended to guide COVID-19 diagnostic device manufactures as their devices transition...
NVIDIA Collaborates with Medtronic to Build AI Platform for Endoscopy Devices
NVIDIA collaborates with Medtronic to integrate NVIDIA’s artificial intelligence (AI) technology into Medtronic’s GI Genius Endoscopy Module.
FDA Seeks $7.2 Billion Budget for 2024
The FDA recently announced that it is seeking a budget of $7.2 Billion for 2024, part of which is intended for “Advancing Medical Product Availability.” The portion of the requested...
Health Tracker Systems Alleges Garmin’s Smartwatch Infringes Patents
Health Tracker Systems LLC (“Health Tracker”) sued Garmin International, Inc. (“Garmin”) for patent infringement in the Central District of California on March 6, 2023. The lawsuit alleges that Garmin’s Forerunner...
Patent on Controlling Access to Drug Delisted from Orange Book
On February 24, 2023, in Jazz Pharms., Inc., v. Avadel CNS Pharms., LLC, the U.S. Court of Appeals for the Federal Circuit affirmed the United States District Court for the District of Delaware’s...
Jury Verdict Against Boston Scientific for $42 Million For Infringement of Patent on Biodegradable Drug-Releasing Implant
On January 31st, 2023, a jury awarded $42 million to medical device company TissueGen in a patent infringement case against Boston Scientific for infringement of U.S. Patent No. 6,596,296, titled...
Medical device innovations and IP: A strategy is everything.
Bringing a medical device to market relies on a broad understanding of IP, explain Sabing Lee and Kregg Koch of Knobbe Martens. The original version of this article was published...
Supreme Court to Weigh in on Fraud Standard under False Claims Act
In a move that may substantially increase healthtech companies’ exposure to monetary damages, the U.S. Supreme Court agreed to weigh in on the key standard for fraud lawsuits under the False...
BioNTech to Ship Modular mRNA Vaccine Factory to Rwanda
Biopharmaceutical New Technologies (BioNTech), the global immunotherapy company based in Mainz, Germany, is scheduled to ship its BioNTainer modular mRNA vaccine factory to Rwanda. According to BioNTech’s press release, the...
Cochlear Implant Developer Agrees to Pay for Alleged False Claims to FDA
Cochlear implant developer Advanced Bionics LLC will pay about $12 million to resolve allegations that it misled federal health care programs, the United States Department of Justice (DOJ) announced. The...
BIOCORP Receives FDA 510(k) Clearance for Smart Injection Sensor
French medical device company BIOCORP announced in a press release that it received FDA 510(k) clearance for Mallya, a device that according to the company allows insulin pen injectors to...
Developments in Patent Disputes Between Apple and AliveCor
Earlier this year, AliveCor, Inc., a medical device and AI company producing electrocardiogram (ECG) hardware and software for consumer mobile devices, succeeded in convincing an International Trade Commission (ITC) judge...
